USA: FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children

From fda.gov/news-events

June 12, 2026: The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an integrated CGM (iCGM) indicated for people two years of age and older who do not use insulin. The FDA previously cleared the Stelo Glucose Biosensor System OTC for individuals 18 years and older in March 2024.

“Children deserve access to the best tools available to manage their health," said Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D. "Today's clearance reflects the FDA's commitment to fostering innovation for paediatric patients and supporting the safe and effective use of medical devices where children live, learn, and play.”

Prediabetes is increasingly impacting children in the United States, placing millions at heightened risk for progressing to Type 2 diabetes. OTC CGMs can play a critical role in addressing this public health concern for paediatric users who do not use insulin. By providing real-time glucose data, these devices can help paediatric patients and their caregivers build greater glycaemic awareness, track patterns in response to meals and exercise, and make informed adjustments to support healthier long-term outcomes and quality of life.

The product is indicated for children, including those with diabetes, who receive oral medication to manage their condition and people who want to understand how diet, exercise, and other lifestyle changes affect their glucose levels.

The Stelo Glucose Biosensor System uses a wearable sensor, paired with an application installed on a compatible smartphone, or other smart device, such as a parent’s or caregiver’s smartphone, to continuously measure, record, analyse and display glucose values. Each sensor lasts for up to 15 days before it must be replaced, although sensor wear time may be shorter in paediatric users than in adults due to several interconnected physiological and behavioural factors. The app displays glucose measurements and trends every 15 minutes. Users and their caregivers should consult their health care provider before making any medication adjustments based on the device’s output.

This clearance is an example of the FDA’s use of real-world evidence (RWE) to support regulatory decision-making. Dexcom and the FDA used previous clinical study data from both paediatrics and adults, along with RWE derived from real-world data on current iCGM use among both groups, to understand expected device performance in paediatric users over the full 15-day wear period.

Participants in the previous study reported mild adverse events including local infection, skin irritation, and pain or discomfort.

For children, the device should be used under the supervision of an adult caregiver. Importantly, this system is not for people with problematic hypoglycaemia (low blood sugar) because it is not designed to alert users when this potentially dangerous condition occurs. This system is also not for people on dialysis. People with a history of disordered eating or eating disorders should talk with their health care provider before using Stelo.

This clearance is also aligned with the FDA’s Home as a Health Care Hub Initiative, which focuses on advancing the development of innovative, patient-centred devices that fit more seamlessly into people’s daily lives at home.

https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor-children 

'Artificial pancreas helps me live without limits'

From bbc.co.uk

A woman with type 1 diabetes has said an artificial pancreas that helps her manage her condition is "brilliant".

Chloe Hammond, 25, from Northampton, was diagnosed with diabetes as a toddler and said the technology monitored her blood sugar levels automatically, delivering insulin when needed.

Type 1 diabetes is caused by the immune system attacking cells in the pancreas that control blood sugar levels and affects about 400,000 people in the UK.

Hammond, who enjoys an active lifestyle and plays ice hockey for Milton Keynes Bolts, said the technology meant she could live "without limitations".

She has had an insulin pump since the age of 10, but benefited from an artificial pancreas when the technology was adopted by the NHS two years ago.

"I have a sensor on my arm; the pump around my waist on a belt," Hammond explained.

"It has a tube that is on a cannula on my stomach. The sensor can track my blood sugar and the pump can relay that information and give a little bit of insulin or stop it.

"The technology has come a long way from constantly carrying around needles. I just wear the device on me – it's brilliant."

Chloe Hammond said playing ice hockey was a way of showing what people with type 1 diabetes were capable of

Speaking to BBC Radio Northampton, Hammond said she enjoyed playing ice hockey and used it as a way to show what people with the condition were capable of.

"If something happens on the ice, people are aware of what it could be. Again, my teammates are thoroughly supportive – they're always checking on me," she said.

"Everyone is supportive of me being in a rough sport with the diabetes."

Hammond added: "It [diabetes] is always on your mind; you're never going to let it slip. It's permanently there for the rest of your life, but you learn to adapt with it.

"Don't let it stop you from doing anything."

https://www.bbc.co.uk/news/articles/ce8px9753zko

New Oral Diabetes Drug Lowers Blood Sugar and Helps With Weight Loss

From libyaupdate.com

Washington – Results from an international clinical trial show that a new oral drug for type 2 diabetes effectively lowers blood sugar levels and leads to significant weight loss. The drug could provide patients with an easier alternative to injectable treatments.

Researchers, led by Mass General Brigham in the United States, said the new medication may expand options for people with type 2 diabetes. The study was published in The Lancet.

Type 2 diabetes is one of the most common chronic diseases. It occurs when the body cannot use insulin properly or does not produce enough, leading to high blood sugar and increased risks of complications such as heart, kidney, nerve, and eye problems.

The researchers tested a new drug called licoglifron, an oral medication still in development. It belongs to the class of GLP-1 receptor agonists, which includes several drugs already used to treat diabetes and obesity.

Licoglifron mimics the effect of the natural GLP-1 hormone by stimulating insulin release when blood sugar rises. It also reduces production of glucagon, the hormone that raises blood sugar, slows stomach emptying, and increases feelings of fullness. These effects help control weight and improve blood sugar management.

The trial included 406 people with type 2 diabetes in nine countries. Participants were randomly assigned to receive different doses of the drug or a placebo.

After 26 weeks of treatment, up to 72.3% of those taking the drug lost at least 5% of their body weight, compared to just 20.2% in the placebo group. The drug also improved blood sugar control. Up to 89.6% of those who took licoglifron achieved an HbA1c level below 7%—the recommended target for most diabetes patients—while only 24.9% of the placebo group reached this goal.

Researchers highlighted that the drug is taken as a pill, unlike most GLP-1 therapies that require injections. This could make treatment easier for patients in the future.

https://libyaupdate.com/new-oral-diabetes-drug-lowers-blood-sugar-and-helps-with-weight-loss/ 

Infections A ‘Major Health Hazard’ For People With Diabetes, Large Study Warns

From healthday.com

Key Takeaways

• Risk of infection is underrecognized in people with diabetes, a new article argues

• People with diabetes have a higher risk of infections treated by either their doctor or a hospital

• This higher risk applies for people with type 1 and type 2 diabetes, and even those with prediabetes

TUESDAY, June 9, 2026 (HealthDay News) — Diabetes wreaks havoc on the body, doing damage to the heart, kidneys, eyes and other major organs.

But one of the most important health risks from diabetes has not gotten the attention it deserves, researchers argue.

Infections should be considered a major health hazard for anyone with diabetes, according to a new study.

People with type 1 diabetes, type 2 diabetes or even prediabetes have a higher risk of serious infections, researchers reported June 6 in the journal Diabetes.

“Infections are a major health hazard across the diabetes spectrum and are hiding in plain sight. They are common, serious and often preventable, yet they are mostly absent from clinical guidelines,” said lead researcher Julia Critchley, a professor of epidemiology at City St George’s, University of London.

“The number of people living with diabetes across the world is on a dangerously steep rise, and it’s a disservice if we do not treat infection risk as a core part of diabetes care,” Critchley said in a news release. “It cannot be an afterthought.”

For the new study, researchers analysed infection rates of more than 800,000 people with either diabetes or prediabetes, comparing them to more than 1 million healthy people matched based on age, sex and ethnicity.

Results showed that people with diabetes had a substantially higher risk of infections treated by a primary doctor or infections severe enough to put them in the hospital:

• People with type 1 diabetes had an 81% higher risk of doctor-treated infection and more than tripled risk of being hospitalized for infection.

• Those with type 1 diabetes had 51% higher odds of an infection treated by their family doctor and a nearly doubled risk of hospitalization.

• Folks diagnosed as prediabetic had a 35% increased risk of doctor-treated infection and 33% higher risk of hospitalization.

Overall, infections were the third-highest underlying cause of death among people with type 2 diabetes, after heart disease and cancer, researchers found.

Pneumonia and other lower respiratory tract ailments were found to be the most common infections that put patients with type 1 and type 2 diabetes in the hospital.

Sepsis and lower respiratory tract infections also were the most common cause of infection-related death among people with type 2 diabetes, researchers found.

Blood sugar levels were found to be tied to increased infection risk:

• For those with type 1 diabetes, higher average blood sugar led to higher risk of infection.

• For those with type 2 diabetes, fluctuating blood sugar levels were linked to severe infections that required hospitalization.

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“Increased infection risk in diabetes should have greater emphasis in U.K., European and U.S. guidance,” Critchley said. “By refreshing guidance on a global scale, it will increase awareness amongst healthcare workers to aid earlier recognition and prompt intervention, which would help reduce avoidable hospital admissions and deaths.”

More information

Yale School of Medicine has more about diabetes and infection risk.

What This Means For You

People with diabetes should be aware that they have an increased risk of infections.

https://www.healthday.com/health-news/diabetes/infections-a-major-health-hazard-for-people-with-diabetes-large-study-warns

Type 2 diabetic says two weeks of going vegan dropped blood sugar from 17 to 5.3: 'I've felt so much better'

From yahoo.com/lifestyle

A Type 2 diabetes patient reported that switching to a vegan diet for about two weeks coincided with a sharp improvement in blood sugar, and the account drew strong encouragement from other users who described comparable experiences.

                                                                                                                      Photo Credit: iStock

What happened?

According to the post on r/PlantBasedDiet, their blood sugar had been running between 15.5 and 17 mmol/L before the diet change. After around 14 days of eating plant-based, they said the number fell as low as 5.3 mmol/L, leading them to think about sticking with it long term.

Describing the change, the poster said they went "full vegan for around a two week period" and that "I've felt so much better" with higher energy. They also reported a drop in blood sugar from persistently elevated readings to levels far closer to normal.

Of course, the results are anecdotal from one person in a sample size of one, but there is some science behind the results, and many hospital diabetes resource centres recommend reducing fat and meat intake. 

At the centre of the discussion was the poster's request for feedback from other people with diabetes on whether going vegan had produced similar changes for them. 

The comment section was overwhelmingly positive, with responses from people dealing with Type 2 diabetes, prediabetes, and Type 1 diabetes. Across those replies, many emphasized that the strongest results were tied not simply to avoiding animal products.

"A low-fat, plant-based (WHOLE plant-based, not just "vegan") diet is excellent for blood sugar control in general, and reducing insulin-resistance in most diabetics, both T1 and T2," a commenter said. "It's so cool that you saw concrete evidence of this in yourself!"

Users also repeatedly referenced the New York Times bestseller "Mastering Diabetes." 

Why does it matter?

People in the thread offered specific examples of improvement. One commenter said a low-fat, low-sugar whole-food plant-based diet brought both their A1C and their spouse's back into the normal range, while another said they moved from a prediabetic 5.8 A1C to normal and that their father went from 11.3 A1C to what they called a reversal.

Another recurring point was the role of saturated fat in insulin resistance, with commenters singling out animal products and some processed oils. In their view, the details of a plant-based diet can be as important as whether it carries the vegan label.

The community's success pointed to the health benefits of eating more plant-based food. Just like in the OP's experience, studies show these diets deliver real health results for eaters, and there're ample benefits for the environment, to boot.

What can I do?

The advice that came up most often was to build meals around whole plant foods instead of relying heavily on processed vegan substitutes.

Several commenters stressed that the "low fat aspect is key," and some warned that palm oil and coconut oil are common ingredients in vegan convenience products.

The idea came up again and again that simple, minimally processed plant foods were favoured, while imitation meats high in saturated fat were seen as less useful for managing blood sugar. 

Overall, the conversation drew a line between the quality of the food and the broad category it falls into. In the thread, many people argued that "whole-food plant-based" and "vegan" do not necessarily mean the same thing, and that the distinction may matter for blood sugar.

https://www.yahoo.com/lifestyle/articles/type-2-diabetic-says-two-200500460.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAL9Y6P5dPbH3UhTA_xAHk5VfT68g1Hf12r4Yxc8bOK3rQqFi2tm8TNFPDgNidrH3z68P5qFkLoHaNcIB1KRGIFx1J9L66Mh-eZS5-Z5T7TH-9NI0YPFpGv2si70td-_3e6HYuyRMN33Z7_Jfo-BArw7pQLPYj5477Fkpt_Kzsin2 

When Should Patients With Diabetes Eat?

From medpagetoday.com

By Hana Kahleova, MD, PhD

Meal timing may be an underused tool

For decades, nutrition counselling in diabetes care has focused primarily on one question: What should patients eat? But a growing body of evidence suggests another question may be clinically important as well: When should patients eat?

Human metabolism follows a circadian rhythm that influences insulin sensitivity, glucose tolerance, beta-cell responsiveness, and energy metabolism across the day. In the morning, metabolic efficiency is generally higher. As the day progresses, glucose tolerance declines and postprandial responses often worsen.

Yet, many patients consume their largest meals in the evening or eat across prolonged daily time windows extending from early morning into late night. From a circadian perspective, this pattern may create a mismatch between food intake and underlying metabolic biology.

Accumulating evidence suggests this mismatch matters.

Controlled feeding studies have demonstrated that identical meals consumed earlier in the day often produce lower postprandial glucose excursions compared with evening intake. Late eating has been associated with impaired glycaemic control, increased insulin resistance, and higher cardiometabolic risk.

In a randomized crossover study my colleagues and I conducted in patients with type 2 diabetes, two larger meals consumed earlier in the day -- breakfast and lunch -- produced greater reductions in body weight, hepatic fat content, fasting glucose, and insulin resistance than six smaller meals of identical caloric content distributed throughout the day.

Similarly, Elizabeth Sutton, PhD, and colleagues demonstrated that early time-restricted feeding improved insulin sensitivity, blood pressure, and oxidative stress markers even without weight loss in men with prediabetes.

These findings suggest that meal timing may influence metabolic outcomes independently of caloric intake alone. Yet, meal timing remains largely absent from routine diabetes care.

Current nutrition counselling appropriately emphasizes dietary quality, caloric balance, fibre intake, and reduction of ultra-processed foods. But patients are rarely advised about circadian alignment, eating windows, or the metabolic implications of late-night intake. This may represent a missed clinical opportunity.

Importantly, meal timing interventions are relatively low-cost, scalable, and behaviourally straightforward compared with many other therapeutic approaches. They do not require additional medications, devices, or invasive procedures. In some patients, they may complement pharmacologic therapies by improving underlying metabolic physiology rather than bypassing it.

This is particularly relevant at a time when healthcare systems are confronting rising rates of obesity and type 2 diabetes alongside escalating demand for costly metabolic therapies, including GLP-1 receptor agonists.

Meal timing is unlikely to replace established pharmacologic treatment. Nor should circadian-based nutrition be oversimplified into rigid dietary rules. Individual variability remains substantial, and more long-term randomized trials are still needed. But the broader principle is increasingly difficult to ignore: metabolism is not static across the day.

As clinicians, we routinely consider timing in other domains of medicine. We time antihypertensives, insulin administration, corticosteroids, chemotherapy, and sleep interventions according to physiologic rhythms and therapeutic response. Nutrition may deserve similar consideration.

Incorporating circadian principles into dietary counselling does not require abandoning existing nutrition recommendations. Rather, it may strengthen them by aligning food intake more closely with human metabolic biology.

For many patients with insulin resistance and type 2 diabetes, the future of nutrition therapy may involve not only improving food quality -- but improving temporal alignment as well. And that shift may turn out to be clinically meaningful.

https://www.medpagetoday.com/opinion/second-opinions/121600

Scientists discovered something surprising about french fries and diabetes

From sciencedaily.com

French fries may be driving potatoes’ bad reputation, while other potato dishes seem far less risky for type 2 diabetes

Summary:

French fries may be the real potato problem. A large study tracking more than 205,000 people for nearly 40 years found that eating three servings of fries per week was linked to a 20% higher risk of developing type 2 diabetes, while baked, boiled, or mashed potatoes showed no significant increase in risk. The research also found that swapping potatoes for whole grains lowered diabetes risk, while replacing them with white rice had the opposite effect.

French fries have long been criticized as an unhealthy food choice, and new research suggests they may deserve that reputation more than other potato dishes.

A large study published in The BMJ found that eating three servings of French fries per week was associated with a 20% higher risk of developing type 2 diabetes. In contrast, consuming the same amount of potatoes prepared in other ways, such as boiled, baked, or mashed, was not linked to a significant increase in diabetes risk.

The research also found that what replaces potatoes in a person's diet matters. Swapping potatoes for whole grains was associated with a lower risk of type 2 diabetes, while replacing them with white rice was linked to a higher risk.

French fries stood out in a massive long-term study, with three weekly servings linked to a 20% higher risk of type 2 diabetes. Credit: Shutterstock

Looking Beyond Potatoes Alone

Potatoes provide important nutrients, including fibre, vitamin C, and magnesium. However, they are also rich in starch and have a relatively high glycaemic index, meaning they can cause blood sugar levels to rise quickly. Because of this, previous studies have often connected potato consumption to a greater risk of type 2 diabetes.

Yet researchers noted that two important factors have often been overlooked. First, potatoes can be prepared in very different ways. Second, the health effects of potatoes may depend on which foods people eat instead.

To explore those questions, scientists examined whether diabetes risk differed between French fries and potatoes prepared by boiling, baking, or mashing. They also evaluated the potential effects of replacing potatoes with other common carbohydrate-rich foods, including whole grains and rice.

Four Decades of Health Data

The study drew on data from more than 205,000 U.S. health professionals who participated in three major long-term studies conducted between 1984 and 2021.

At the start of the research, participants did not have diabetes, heart disease, or cancer. Every four years, they completed detailed dietary questionnaires that allowed researchers to track eating habits over time.

During nearly 40 years of follow-up, 22,299 participants developed type 2 diabetes.

After accounting for lifestyle habits and dietary factors that could influence diabetes risk, researchers found that every three weekly servings of potatoes overall were associated with a 5% increase in the rate of type 2 diabetes.

The strongest association, however, involved French fries. Every three servings per week were linked to a 20% increase in the rate of type 2 diabetes. Similar consumption of baked, boiled, or mashed potatoes was not associated with a statistically significant increase.

Whole Grains Show a Benefit

Researchers also looked at what happened when potatoes were replaced with other foods.

Replacing three weekly servings of potatoes with whole grains was associated with an 8% lower rate of type 2 diabetes. When baked, boiled, or mashed potatoes were replaced with whole grains, the rate was 4% lower. Replacing French fries with whole grains was associated with a 19% lower rate.

The results were different when potatoes were replaced with white rice. Substituting either total potato intake or baked, boiled, or mashed potatoes with white rice was associated with a higher rate of type 2 diabetes.

Important Caveats

Because this was an observational study, it cannot prove that French fries directly cause diabetes. The researchers acknowledge that other factors not measured in the study may have contributed to the results.

The participants were also predominantly health professionals of European ancestry, which means the findings may not apply equally to all populations.

Even so, the researchers wrote: "Our findings underscore that the association between potato intake and type 2 diabetes risk depends on the specific foods used as replacement. The findings also align with current dietary recommendations that promote the inclusion of whole grains as part of a healthy diet for the prevention of type 2 diabetes."

Are Potatoes Back on the Menu?

In an accompanying editorial, researchers argued that potatoes should not be viewed as a single category when considering health effects.

They emphasized that both preparation methods and replacement foods are important factors when making dietary recommendations or shaping public policy.

According to the editorial, baked, boiled, and mashed potatoes can fit into a healthy and environmentally sustainable diet because of their relatively low environmental impact and overall nutritional value. However, the authors noted that whole grains should remain a priority food choice for reducing diabetes risk.

They also called for future studies involving more diverse populations and analyses that continue to examine both cooking methods and food substitutions.

https://www.sciencedaily.com/releases/2026/06/260603015218.htm